ERP Systems Analyst

INCOG BioPharma; Fishers (IN); Hybrid; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

INCOG BioPharma in Fishers, IN seeks a Senior ERP Systems Analyst to support and sustain SAP Business ByDesign in a regulated CDMO environment. You will manage configurations, user access, and integrations, ensuring ongoing compliance with GxP and FDA-related requirements.

You will collaborate with stakeholders, the implementation partner, and cross-functional teams to maintain a stable, validated ByDesign platform and uphold documentation standards.

Qualifikationen

• 3-5 years hands-on experience supporting or administering SAP Business ByDesign or equivalent cloud ERP.
• Experience with GxP-regulated environments and CSA/CSV concepts.
• Ability to manage user provisioning, roles, and access control.

Aufgaben

• Support and administer SAP ByDesign in FI/MM/Procurement/Inventory areas in a GxP environment.
• Handle user provisioning, role assignments, and access controls per SoD and 21 CFR Part 11.
• Troubleshoot issues, document changes, and ensure change control is followed.
• Maintain master data, configuration docs, and audit-ready records.
• Assist with system validation, risk assessments, and QA activities.

Kenntnisse

Troubleshooting

System administration

Documentation

Regulatory compliance

Communication

Ausbildung

B.S. in Information Technology/Computer Science/Business/Life Sciences

Tools

SAP Business ByDesign

Jira Service Manager

Scan4Cloud WMS

Jobbeschreibung

Are you an IT professional looking for an exciting opportunity with an organization where you can have an impact on global health and wellness?

We are looking for a Senior ERP Systems Analyst who will help with our growing IT department. Do you naturally create new ways to deliver exceptional results? We want to meet you!

Role Summary

The ERP Systems Analyst - SAP Business ByDesign is a hands-on system support resource responsible for the day-to-day administration, configuration support, troubleshooting, and compliance maintenance of INCOG's SAP Business ByDesign ERP platform. Reporting to the Associate Director of Enterprise Systems, this role works closely with business stakeholders, the implementation partner, and cross-functional teams to ensure ByDesign remains stable, compliant, and aligned with INCOG's operational and GxP requirements.

This role is focused on sustaining and supporting the existing ByDesign environment - managing user needs, system configurations, integrations, and documentation in a regulated CDMO setting.

Essential Job Functions

SAP Business ByDesign System Support & Administration

• Support and maintain SAP Business ByDesign configurations across functional areas including Financial Management (FI), Materials Management (MM), Procurement, Inventory, and Warehousing, ensuring system settings remain aligned with approved business requirements and INCOG's GxP-compliant baseline.
• Perform day-to-day system administration tasks including user provisioning, role assignments, and access management in accordance with Segregation of Duties (SoD) principles and 21 CFR Part 11 access control requirements.
• Troubleshoot and resolve system issues, configuration discrepancies, and user-reported defects in a timely manner, escalating to the implementation partner or SAP support when required.
• Assist with the execution of system changes and enhancements, ensuring all modifications are processed through the appropriate change control workflow and documented in accordance with INCOG SOPs.
• Support master data maintenance activities for assigned functional areas, including data entry validation, periodic reviews, and coordination with business process owners to ensure ongoing data integrity.
• Maintain and update configuration documentation, including work instructions, configuration records, and system change logs, ensuring records are current and inspection ready.

GxP Compliance & System Validation Support

• Support Computer System Assurance (CSA) activities for SAP Business ByDesign, assisting in the execution of risk assessments, test scripts, and validation documentation in alignment with GAMP 5 principles and INCOG's validation framework.
• Assist in maintaining the ByDesign validated state by ensuring all changes and configuration updates are assessed for compliance impact prior to implementation and executed through a documented, audit-trail-compliant change control process.
• Participate in periodic system reviews, user access reviews (UARs), and audit trail reviews, supporting ongoing compliance and flagging potential gaps to the Senior Manager of Enterprise Systems.
• Apply working knowledge of FDA 21 CFR Part 11, GAMP 5, and applicable data integrity guidance as they relate to ERP systems in a GxP manufacturing environment.
• Support preparation for FDA inspections and internal audits by ensuring that system documentation, configuration records, and change histories are complete, organized, and readily available.

Integrations & System Connectivity Support

• Support the ongoing operation and troubleshooting of integrations between SAP Business ByDesign and connected systems, including WMS and other operational platforms, coordinating with the implementation partner and relevant vendors as needed.
• Monitor integration health, identify errors or data flow issues, and elevate corrective actions to maintain interface integrity and data quality across the enterprise system landscape.
• Assist in documenting integration configurations, data mapping specifications, and error-handling procedures, ensuring records are current and accessible.

Operations, Incident Management & Continuous Improvement

• Serve as a primary point of contact for day-to-day ERP support requests, managing tickets in Jira Service Manager and ensuring timely resolution within defined SLA targets.
• Assist in root cause analysis for recurring system issues, contributing to corrective action recommendations and supporting implementation of preventive measures.
• Identify and communicate configuration inefficiencies, usability issues, and process improvement opportunities to the Senior Manager of Enterprise Systems.
• Stay current on SAP Business ByDesign release notes and updates, assessing potential impacts to existing configurations and validated workflows and communicating relevant findings to the team.

Documentation & Knowledge Support

• Author and maintain SAP-related SOPs, work instructions, user guides, and training materials, ensuring all documentation meets GxP standards and is inspection-ready.
• Support end-user training efforts by developing job aids, conducting system walkthroughs, and providing guidance on proper use of ByDesign functionality.
• Maintain accurate and complete records of system configurations, changes, and support activities, contributing to INCOG's overall documentation governance and audit readiness.

Special Job Requirements

• 3-5 years of hands-on experience supporting or administering SAP Business ByDesign or a comparable cloud-based ERP platform in a business environment.
• Demonstrated working knowledge of one or more SAP ByDesign functional areas such as Financial Management, Procurement, Inventory & Warehousing, or Supply Chain.
• Familiarity with GxP-regulated environments and an understanding of Computer System Assurance (CSA/CSV) principles, including GAMP 5 and 21 CFR Part 11 requirements as they apply to ERP systems.
• Experience performing system administration activities including user provisioning, role management, and access control in a regulated environment.
• Ability to troubleshoot configuration issues, manage support tickets, and communicate effectively with business users and technical teams.
• Strong documentation skills with attention to detail, particularly for GxP-compliant records, change control entries, and system support logs.
• B.S. in Information Technology, Computer Science, Business, Life Sciences, or equivalent experience.

Additional Preferences

• Experience supporting ERP systems in a pharmaceutical, biotech, medical device, or CDMO manufacturing environment.
• Familiarity with SAP Business ByDesign adaptation and extensibility tools, including fine-tuning activities and report configuration.
• Familiarity with Scan4Cloud WMS, including its integration with SAP Business ByDesign, is a plus.
• Working knowledge of data integrity principles and master data governance practices in a GxP setting.
• Experience supporting system integrations between ERP and adjacent platforms such as WMS, LIMS, or quality systems.
• SAP Business ByDesign certification or completion of SAP ByDesign training courses is a plus.
• Experience using Jira or similar IT service management tools for ticket tracking and SLA management.

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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